A Phase 4 interventional study of Evolocumab and Placebo in Diabetes Mellitus, Type 2, Dyslipidemia Associated With Type II Diabetes Mellitus and Percutaneous Coronary Intervention, sponsored by Inova Health Care Services. Terminated at 1 site in United States. Per ClinicalTrials.gov, last updated 2023-01-19.
Sponsored by Inova Health Care Services · Phase 4, Interventional, and Prevention
Prospective, single center, double-blind, randomized pharmacodynamic experimental study. The study will enroll 150 subjects with ASCVD on optimal statin therapy as per physician and Diabetes Mellitus (DM) undergoing elective Percutaneous Coronary Intervention (PCI). Eligible patients will be randomized for 30 day treatment to either 1) evolocumab 420 mg ; or 2) placebo.
This is a double-blind randomized clinical trial of evolocumab versus placebo in patients with ASCVD and DM on clopidogrel and aspirin undergoing PCI. The study is aimed to assess
Eligible patients will be randomized prior to start the PCI equally to either:
The laboratory assessments will be performed before (baseline), and 16-24 hours and 30-days after randomization.
Subject participation will be 30 days from the randomization.
Exclusion Criteria:
75 subjects on optimal statin therapy undergoing elective PCI will receive evolocumab 420mg.
Drug: Evolocumab
75 subjects on optimal statin therapy undergoing elective PCI will receive placebo
Drug: Placebo
Patients will receive evolocumab 420 mg administered subcutaneously
Also known as: Repatha
Patients will receive placebo administered subcutaneously
Change From Baseline in Adenosine Diphosphate (ADP) Stimulated P-selectin Expression
Change from baseline in ADP-stimulated P-selectin expression (% Positive Cells) as measured by flow cytometry between treatment groups (420 mg evolocumab treatment and placebo).
Time frame: Baseline and after 30 days of treatment
Change in ADP-unstimulated P-selectin Expression
Change in ADP-unstimulated P-selectin expression (% Positive Cells) between treatment groups (420 mg evolocumab treatment and placebo)
Time frame: Baseline and after 30 days of treatment
Change in ADP-stimulated Lectin-like oxLDL [Oxidized Low-density Lipoprotein] Receptor-1 Mean Fluorescence Intensity (MFI)
Change in ADP-stimulated LOX-1 (MFI) as measured by flow cytometry between treatment groups (420 mg evolocumab treatment and placebo)
Time frame: Baseline and after 30 days of treatment
Change in ADP-stimulated Cluster of Differentiation (CD)-147 MFI
Change in ADP-stimulated CD-147 mean fluorescence intensity (MFI) as measured by flow cytometry between treatment groups (420 mg evolocumab treatment and placebo)
Time frame: Baseline and after 30 days of treatment
| Milestone | Evolocumab 420mg | Placebo |
|---|---|---|
| Started | 3 | 1 |
| Completed | 3 | 1 |
| Not completed | 0 | 0 |
Change from baseline in ADP-stimulated P-selectin expression (% Positive Cells) as measured by flow cytometry between treatment groups (420 mg evolocumab treatment and placebo).
| % Positive Cells | Evolocumab 420mg | Placebo |
|---|---|---|
| Baseline | 45.2 ± 17.1 | — |
| 30 Days | 47.8 ± 18.8 | — |
Change in ADP-unstimulated P-selectin expression (% Positive Cells) between treatment groups (420 mg evolocumab treatment and placebo)
| % Positive Cells | Evolocumab 420mg | Placebo |
|---|---|---|
| Baseline | 5.4 ± 2.7 | — |
| 30 Days | 8.8 ± 2.9 | — |
Change in ADP-stimulated LOX-1 (MFI) as measured by flow cytometry between treatment groups (420 mg evolocumab treatment and placebo)
| MFI | Evolocumab 420mg | Placebo |
|---|---|---|
| Baseline | 1186 ± 1017 | — |
| 30 Days | 721 ± 82 | — |
Change in ADP-stimulated CD-147 mean fluorescence intensity (MFI) as measured by flow cytometry between treatment groups (420 mg evolocumab treatment and placebo)
| MFI | Evolocumab 420mg | Placebo |
|---|---|---|
| Baseline | 1459 ± 1220 | — |
| 30 Days | 678 ± 148 | — |
Collected over 30 Days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Evolocumab 420mg | 0/3 (0%) | 1/3 (33.3%) | 1/3 (33.3%) |
| Placebo | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Event | Evolocumab 420mg | Placebo |
|---|---|---|
| Chest painCardiac disorders | 1/3 | 0/1 |
| Event | Evolocumab 420mg | Placebo |
|---|---|---|
| rashSkin and subcutaneous tissue disorders | 1/3 | 0/1 |
| Age, Continuous(years) | Evolocumab 420mg | Placebo | Total |
|---|---|---|---|
| Mean | 70 ± 8 | 67 ± 0 | 69 ± 7 |
| Sex: Female, Male(Participants) | Evolocumab 420mg | Placebo | Total |
|---|---|---|---|
| Female | 1 | 0 | 1 |
| Male | 2 | 1 | 3 |
| Race (NIH/OMB)(Participants) | Evolocumab 420mg | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 3 | 1 | 4 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
Documents are hosted by the registry — open the source record to download them.
This study is terminated, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Inova Health Care Services